Pfizer's ADHD Portfolio: Quillivant XR and QuilliChew ER

IMPORTANT SAFETY INFORMATION AND INDICATION

WARNING: ABUSE AND DEPENDENCE

CNS stimulants, including Quillivant XR, QuilliChew ER, other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy.

Quillivant XR and QuilliChew ER are contraindicated:

In patients known to be hypersensitive to methylphenidate or other components of Quillivant XR and QuilliChew ER. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported.

During treatment with monoamine oxidase inhibitors (MAOIs), and also within 14 days following discontinuation of treatment with an MAOI because of the risk of hypertensive crisis.

Sudden death, stroke, and myocardial infarction have occurred in adults treated with CNS stimulants at recommended doses. Sudden death has occurred in pediatric patients with structural cardiac abnormalities and other serious cardiac problems, and in adults taking CNS stimulants at recommended doses for ADHD. Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmias, coronary artery disease, or other serious cardiac problems. Further evaluate patients who develop exertional chest pain, unexplained syncope, or arrhythmias during treatment with Quillivant XR or QuilliChew ER.

CNS stimulants cause an increase in blood pressure (mean increase approximately 2-4 mm Hg) and heart rate (mean increase approximately 3-6 bpm). Some individuals may have larger increases. Monitor all patients for hypertension and tachycardia.

Use of stimulants may cause psychotic or manic symptoms in patients with no prior history, or exacerbation of symptoms in patients with pre-existing psychiatric illness. Evaluate for bipolar disorder prior to Quillivant XR or QuilliChew ER use.

Cases of painful and prolonged penile erections and priapism have been reported with methylphenidate products. Immediate medical attention should be sought if signs or symptoms of prolonged penile erections or priapism are observed.

Stimulants used to treat ADHD are associated with peripheral vasculopathy, including Raynaud's phenomenon. Signs and symptoms are usually intermittent and mild; however, very rare sequelae include digital ulceration and/or soft tissue breakdown. Careful observation for digital changes is necessary during treatment with ADHD stimulants.

CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. Growth should be monitored during treatment with stimulants, including Quillivant XR and QuilliChew ER. Patients who are not growing or gaining weight as expected may need to have their treatment interrupted.

QuilliChew ER contains phenylalanine, a component of aspartame, and can be harmful to patients with phenylketonuria (PKU).

Based on accumulated data from other methylphenidate products, the most common (≥5% and twice the rate of placebo) adverse reactions are:

Appetite decreased

Insomnia

Nausea

Vomiting

Dyspepsia

Abdominal pain

Weight decreased

Anxiety

Dizziness

Irritability

Affect lability

Tachycardia

Blood pressure increased

Appetite decreased

Insomnia

Nausea

Vomiting

Dyspepsia

Abdominal pain

Weight decreased

Anxiety

Dizziness

Irritability

Affect lability

Tachycardia

Blood pressure increased

There is limited experience with Quillivant XR and QuilliChew ER in controlled trials.

CNS stimulant medications, such as Quillivant XR and QuilliChew ER, can cause vasoconstriction and thereby decrease placental perfusion. No fetal and/or neonatal adverse reactions have been reported with the use of therapeutic doses of methylphenidate during pregnancy; however, premature delivery and low birth weight infants have been reported in amphetamine-dependent mothers.

The developmental and health benefits of breastfeeding should be considered along with a mother’s clinical need for Quillivant XR and QuilliChew ER and any potential adverse effects on the breastfed infant from Quillivant XR and QuilliChew ER or from the underlying maternal condition. Monitor breastfeeding infants for adverse reactions, such as agitation, insomnia, anorexia, and reduced weight gain.

Support & Services

Quillivant XR® liquid and QuilliChew ER® chewable tablets each provide flexibility with multiple dosage strengths, and different duration options, to meet the individual needs* of your patients with ADHD ages 6 years and above.

*Prior to treating pediatric patients and adults with CNS stimulants, including Quillivant XR and QuilliChew ER, assess for the presence of cardiac disease (ie, perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam). The recommended starting dose for Quillivant XR and QuilliChew ER is 20 mg given orally once daily in the morning. Dosage for Quillivant XR may be increased or decreased weekly in increments of 10 mg to 20 mg per day. Dosage for QuilliChew ER may be increased or decreased weekly in increments of 10, 15, or 20 mg per day. Daily dosage above 60 mg for Quillivant XR and QuilliChew ER is not recommended. Reduce dosage or discontinue therapy if patients exhibit paradoxical aggravation of symptoms or other adverse events, or if improvement is not observed after an appropriate dose adjustment over a 1-month period.

IMPORTANT SAFETY INFORMATION AND INDICATION

WARNING: ABUSE AND DEPENDENCE

CNS stimulants, including Quillivant XR, QuilliChew ER, other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy.

Quillivant XR and QuilliChew ER are contraindicated:

In patients known to be hypersensitive to methylphenidate or other components of Quillivant XR and QuilliChew ER. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported.

During treatment with monoamine oxidase inhibitors (MAOIs), and also within 14 days following discontinuation of treatment with an MAOI because of the risk of hypertensive crisis.

Sudden death, stroke, and myocardial infarction have occurred in adults treated with CNS stimulants at recommended doses. Sudden death has occurred in pediatric patients with structural cardiac abnormalities and other serious cardiac problems, and in adults taking CNS stimulants at recommended doses for ADHD. Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmias, coronary artery disease, or other serious cardiac problems. Further evaluate patients who develop exertional chest pain, unexplained syncope, or arrhythmias during treatment with Quillivant XR or QuilliChew ER.

CNS stimulants cause an increase in blood pressure (mean increase approximately 2-4 mm Hg) and heart rate (mean increase approximately 3-6 bpm). Some individuals may have larger increases. Monitor all patients for hypertension and tachycardia.

Use of stimulants may cause psychotic or manic symptoms in patients with no prior history, or exacerbation of symptoms in patients with pre-existing psychiatric illness. Evaluate for bipolar disorder prior to Quillivant XR or QuilliChew ER use.

Cases of painful and prolonged penile erections and priapism have been reported with methylphenidate products. Immediate medical attention should be sought if signs or symptoms of prolonged penile erections or priapism are observed.

Stimulants used to treat ADHD are associated with peripheral vasculopathy, including Raynaud's phenomenon. Signs and symptoms are usually intermittent and mild; however, very rare sequelae include digital ulceration and/or soft tissue breakdown. Careful observation for digital changes is necessary during treatment with ADHD stimulants.

CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. Growth should be monitored during treatment with stimulants, including Quillivant XR and QuilliChew ER. Patients who are not growing or gaining weight as expected may need to have their treatment interrupted.

QuilliChew ER contains phenylalanine, a component of aspartame, and can be harmful to patients with phenylketonuria (PKU).

Based on accumulated data from other methylphenidate products, the most common (≥5% and twice the rate of placebo) adverse reactions are:

Appetite decreased

Insomnia

Nausea

Vomiting

Dyspepsia

Abdominal pain

Weight decreased

Anxiety

Dizziness

Irritability

Affect lability

Tachycardia

Blood pressure increased

Appetite decreased

Insomnia

Nausea

Vomiting

Dyspepsia

Abdominal pain

Weight decreased

Anxiety

Dizziness

Irritability

Affect lability

Tachycardia

Blood pressure increased

There is limited experience with Quillivant XR and QuilliChew ER in controlled trials.

CNS stimulant medications, such as Quillivant XR and QuilliChew ER, can cause vasoconstriction and thereby decrease placental perfusion. No fetal and/or neonatal adverse reactions have been reported with the use of therapeutic doses of methylphenidate during pregnancy; however, premature delivery and low birth weight infants have been reported in amphetamine-dependent mothers.

The developmental and health benefits of breastfeeding should be considered along with a mother’s clinical need for Quillivant XR and QuilliChew ER and any potential adverse effects on the breastfed infant from Quillivant XR and QuilliChew ER or from the underlying maternal condition. Monitor breastfeeding infants for adverse reactions, such as agitation, insomnia, anorexia, and reduced weight gain.